Kornimate/medical-research-clean huggingface dataset:
assessment of lotrafilcon a contact lenses

Conditions: Myopia

Summary: the purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.


Eligibility criteria:
inclusion criteria: * have normal ocular findings. * be able to wear the study lenses in the available powers. * currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day. * wear night \& day contact lenses. * other protocol-defined inclusion criteria may apply. exclusion criteria: * require concurrent ocular medication. * eye injury or surgery within twelve weeks prior to enrollment. * currently enrolled in an ophthalmic clinical trial. * any active corneal infection. * corneal refractive surgery. * wear air optix night \& day aqua lenses. * other protocol-defined exclusion criteria may apply.
effect of clarithromycin on the pharmacokinetics of apixaban in healthy participants

Conditions: Venous Thromboembolism

Summary: this study is to evaluate the effects of multiple-dose clarithromycin on the single-dose pharmacokinetics (pk) of apixaban with parameters like cmax, auc(inf), and auc(0-t).


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. target population: healthy subjects as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ecg), and clinical laboratory tests including coagulation parameters. 3. subjects with body mass index of 18 to 30 kg/m2, inclusive 4. women must not be breast feeding, have a negative serum or urine pregnancy test and must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatments apixaban and clarithromycin plus 5 half-lives of study treatments apixaban and clarithromycin plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion. 5. men who are sexually active with wocbp must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatments apixaban and clarithromycin plus 5 half-lives of the study treatment plus 30 days for a total of 33 days post-treatment completion. in addition, male participants must be willing to refrain from sperm donation during this time. exclusion criteria: 1. history of any significant medical illness, drug allergy including allergy to apixaban, fxa inhibitors (and/or their excipients), clarithromycin, macrolides, and/or related compounds. history of substance abuse and use of nicotine containing products and/or alcohol abuse. 2. history of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation, including hypermenorrhea, intra-cranial hemorrhage, family history of bleeding disorders in first degree relatives, and/or any adverse reaction to anticoagulants or antiplatelet agents that resulted in excessive bleeding. 3. history of recurrent neurological or gastrointestinal disorders, including insomnia, chronic headaches, dizziness, gastroesophageal reflux disease, cholecystectomy, gastric ulcers and/or gilbert's syndrome. 4. history of antibiotic induced secondary infections, including candidiasis. 5. evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg, or clinical laboratory tests beyond what is consistent with the target population.
bypass or thurpass for superficial femoral artery occlusion? scandinavian thurpass study

Conditions: Femoral Artery Occlusion

Summary: the aim of the study is to compare ptfe-graft bypass surgery versus viabahn endoprosthesis for femoropopliteal arterial occlusion in intermittent claudication and critical ischaemia in patients who would be technically amenable for both treatments. the primary objective is to compare primary patencies of the two treatments. the secondary objective of the study is to evaluate secondary patency, functional status, the quality of life and costs of the new endovascular therapy.

femoropopliteal bypass graft surgery with ptfe-prosthesis has proven to be an acceptable treatment for stable incapacitating claudication and critical ischaemia in patients with superficial femoral artery occlusion. preliminary results of a thrupass endoprosthesis in the treatment of femoral lesions are promising. less morbidity and better cost-effectiveness are suggested to be achieved in treatment of chronic lower limb ischaemia with endovascular treatment comparing to surgical treatment. a randomised multicentre trial aims to enrol a pilot group of 60 + 60 patients to be followed for 3 years. patients are treated either with viabahn thrupass endoprosthesis (gore corp.) or with 6 mm ptfe-prosthesis bypass graft surgery. primary patency at three years is the primary end point and secondary patency, functional success, costs and quality of life are the secondary end points.

Eligibility criteria:
inclusion criteria: 1. superficial femoral artery occlusion from 5 to 25 cm in length above the knee joint. 2. patient must be equally eligible for both procedures. 3. patient must present intermittent claudication with resistance to medical therapy and exercise or critical ischaemia. 4. normal adjacent vessel diameter must be between 4.8 and 6.5 mm. 5. at least one patent distal run-off vessel and at least 1 cm of healthy superficial femoral artery below and above the lesion to allow proper placement of the endoprosthesis. 6. patient must be 18 years or older. 7. women of childbearing age must have negative pregnancy test prior to inclusion. exclusion criteria: 1. known allergy or contraindications to aspirin, clopidogrel, dipyridamole or anticoagulants. 2. bleeding diatheses 3. presence of one or several previously placed endoprosthesis or grafts in the superficial femoral artery segment. 4. planned other endovascular therapy of the same segment. 5. other than 6-7 mm diameter endoprosthesis or 6 mm ptfe-prosthesis is needed. 6. presence of evolving malignant cancer or any other illness posing an immediate threat to life. 7. life-expectancy less than 2 years due to co-morbidity or other situation that would make the patient unlikely candidate for follow-up visits. 8. participation in another vascular clinical study less than 30 days prior to inclusion. 9. patients unable to fill out the prescribed quality of life questionnaires themselves or unable to understand the full meaning of the informed consent.

Keywords: superficial femoral artery occlusion (tasc ii b or c)
optimizing fluid status

Conditions: Hypotension During Dialysis

Summary: title of study: optimizing fluid status study code: hd-iit-01-e study design: prospective open design in study centre at two locations applied medical device: body composition monitor (bcm) for determination of fluid overload and dry weight aim of the study: to improve the fluid status in chronic hd patients (measured as oh (overhydration) or tafo (time averaged fluid overload)) based on bcm measurements. up to now, the bcm was occasionally applied in both locations of the study centre. study hypothesis: regular measurement of fluid status (assessed by bcm) and display of dry weight (post-weight plan)will have significant consequences, namely a decrease of the: * time averaged fluid overload (tafo), * proportion of patients with severe overhydration oh \> 2.5 l,or oh/ecw \> 15 %) * proportion of dehydrated patients (oh \< -1.0 l, or oh \< -7 %), * mean overhydration, * variance of overhydration, * time outside the reference range (-1.0l \< oh \< 2.5l). devices used in this study: dialysis machine 5008 equipped with blood pressure monitor bpm, blood volume monitor bvm, blood temperature monitor btm, and online clearance monitor ocm ; body composition monitor bcm ; data management software / database system nephrolink disposables used in this study: bvm blood lines and bcm electrodes patients: 60 patients


Eligibility criteria:
inclusion criteria: * chronic renal failure stage v * treatment thrice weekly with hd or on-line hdf for at least 6 months prior to inclusion * ability to understand the nature and requirements of the study * age: at least 18 years * signed informed consent. exclusion criteria: * interventional clinical study during the preceding 30 days or previous participation in the same study * acute or chronic infection (hiv, hepatitis b or c, ...) * severe disease (malignant tumour, tuberculosis ...) * usually single needle hd * problems with shunt or high recirculation, * severe intra-dialytic blood pressure instability in the last month * instable angina pectoris * major amputation at arm or leg, or a pacemaker.

Keywords: bioimpedance overhydration dry weight
lung stereotactic body radiotherapy (sbrt) delivered over 4 days versus 11 days

Conditions: Peripherally Located Stage I Lung Cancer; Peripherally Located Solitary Lung Metastasis

Summary: stereotactic body radiotherapy (sbrt) has emerged as a new treatment option for peripherally located lung tumours, offering very high rates of tumour eradication, with minimal side effects. even though this treatment option is being adopted in more and more cancer centres, there is still no consensus about the optimal schedule for the radiation treatment. generally speaking, most lung sbrt schedules involve delivering 3-4 days of radiation. at the sunnybrook odette cancer centre, the lung sbrt policy is to deliver 4 days of radiation over 11 days (each treatment given once very 3rd day). however, some centres deliver the same treatment over 4 days in a row (each treatment given once daily over 4 days). there is no evidence from the published literature to suggest that there is any difference in side effects between delivering the sbrt over 4 days versus 11 days. to confirm this, the investigators propose to conduct a comparative (randomized) study to compare these 2 approaches.


Eligibility criteria:
inclusion criteria: * pathologic diagnosis of malignancy in the lung (either nsclc or metastasis) * if pathologic diagnosis is not available, there must be evidence of fdg uptake on pet-ct suggestive of malignancy and/or evidence of tumour growth over serial ct scans * clinical stage i lung cancer or solitary lung metastasis located in the periphery away from central mediastinal structures and \<=5cm in size * patient deemed suitable for lung sbrt (reasonable performance status, acceptable pulmonary function) by the attending radiation oncologist
phase 2a study of hpg1860 in subjects with nash

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: this is a phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of hpg1860 versus placebo in subjects with biopsy-confirmed or phenotypic nash.

this is a phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of hpg1860 versus placebo in subjects with biopsy-confirmed or phenotypic nash. screening will occur up to 5 weeks prior to randomization; all eligible subjects will have baseline hepatic imaging during screening, prior to randomization. approximately 80 eligible subjects will be randomized 1:1:1:1 on day 1/week 0 (t1) to receive either hpg1860 3 mg (n = 20), or 5 mg (n = 20), or 8 mg (n = 20), or placebo (n = 20) for 12 weeks. following a preplanned interim analysis, a dose cohort may be dropped and/or added.

Eligibility criteria:
inclusion criteria: 1. provision of written informed consent prior to any study-specific procedure. 2. males and females between 18 and 75 years of age 3. nonpregnant, nonlactating women. 4. male subjects must agree to utilize a highly effective method of contraception. 5. body mass index (bmi) of ≥25 kg/m2 at screening. 6. non-cirrhotic nash subjects. 7. nash subjects with hepatic fat assessed by a central reader 8. willing and able to adhere to study restrictions and agree to comply with study protocol. exclusion criteria: 1. pregnant or lactating females 2. current significant alcohol consumption 3. elevated ldl-c with stable dose of statin an or pcsk9 inhibitor 4. renal dysfunction or nephritic syndrome or a history of nephritis 5. recent infarction, unstable angina leading to hospitalization, uncontrolled, symptomatic cardiac arrhythmia 6. uncontrolled hypertension 7. type 1 diabetes or uncontrolled t2dm 8. uncontrolled hypothyroidism 9. liver transplant and/or other significant liver disease or dysfunction 10. hiv antibody positive 11. known hypersensitivity or formulation excipient 12. gastrointestinal conditions or procedures that may affect drug absorption 13. hematologic or coagulation disorders 14. unstable weight within the last 3 months 15. active malignancy 16. unexplained creatine kinase (ck) \>3 × uln 17. blood donation, blood transfusion 18. unable to undergo or contraindication to mri procedure 19. a medical or situational finding that in the investigator's opinion may compromise the subject's safety or ability to complete the study.

Keywords: nash
clevidipine in the treatment of blood pressure in patients with acute heart failure (pronto)

Conditions: Hypertension; Heart Failure

Summary: the purpose of this study was to evaluate the efficacy and safety of intravenous (iv) clevidipine as compared with standard of care iv antihypertensive agents for blood pressure (bp) lowering in patients with acute heart failure and elevated bp.

this study was an open-label randomized efficacy and safety pilot trial in patients with acute heart failure (ahf) and hypertension (systolic blood pressure \[sbp\] ≥160 mm hg) requiring parenteral antihypertensive therapy. eligible patients were randomized to receive clevidipine or standard of care (soc) intravenous antihypertensive treatment in an open-label manner in a ratio of 1:1. at the time of randomization, a patient-specific, prespecified sbp target range was determined and be recorded, prior to study drug treatment. information on the dosing regimen, use of additional or alternative agents and transition to oral therapy if needed is detailed in the study 'arm' and 'intervention' sections. a data safety monitoring board was utilized periodically throughout the study to monitor the safety of patients. adverse events were assessed for 7 days post-study randomization or hospital discharge, whichever occured first. serious adverse events (saes) were assessed for 30 days following study randomization. subjects were contacted by telephone or in person up to 5 days after their 30-day time point to determine if any saes occurred following study drug treatment and to follow up on the heath economic assessments.

Eligibility criteria:
inclusion criteria: * age 18 years or older * presentation consistent with acute heart failure and pulmonary congestion on physical examination as evidenced by rales * baseline systolic blood pressure (immediately prior to initiation of study drug) of ≥160 mm hg * dyspnea score (sitting) of at least 5 on a 10 cm visual analog scale (vas) * required iv antihypertensive therapy to lower blood pressure * written informed consent exclusion criteria: * administration of an agent (iv or oral) for the treatment of elevated bp within the previous 2 hours of randomization. (previous short-acting non-iv nitrates, continuous positive airway pressure (cpap), and bi-level positive airway pressure (bipap) were permitted) * chest pain and/or electrocardiogram with st segment changes consistent with acute coronary syndrome * known or suspected aortic dissection * acute myocardial infarction within the prior 14 days * dialysis-dependant renal failure * requirement for immediate endotracheal intubation * positive pregnancy test, known pregnancy or breast feeding female * intolerance or allergy to calcium channel blockers * allergy to soybean oil or egg lecithin * known liver failure, cirrhosis or pancreatitis * prior directives against advanced life support * participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment

Keywords: hypertension antihypertensive agent calcium channel blocker
bioequivalence study of torrent pharmaceutical limited's ismn 120 mg er tablets under fasting condition

Conditions: Healthy

Summary: objective: to compare the single dose bioavailability of torrent's isosorbide mononitrate 120 mg er tablets (test) and isosorbide mononitrate 120 mg er tablets (reference) of kremers urban, usa. dosing periods were separated by a washout period of 8 days. study design: randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects


Eligibility criteria:
inclusion criteria: * healthy males within the age range of 18 to 55 years. * a body mass index within 18-25 kg/m2. * given written informed consent to participate in the study. * absence of diseases markers of hiv 1 \& 2, hepatitis b \& c virus and rpr. * absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history and physical examination during the screening. * a normal 12-lead ecg. * a normal chest x-ray. * comprehension of the nature and purpose of the study and compliance with the requirements of the entire protocol. * no history or no evidence of hypersensitivity or idiosyncratic reactions to other nitrates or nitrites. * no history of allergic rash. * no history of significant systemic diseases. * no history of psychiatric disorders or addiction to any recreational drug or drug dependence. * no donation of blood within 56 days prior to study check-in. * no participation in any clinical study within the past 56 days. * no receipt of any prescription drugs or otc products, with in two weeks prior to study check-in. * no history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study check-in. * no family history of neurological disorders. * not consumed alcohol and xanthine containing food and beverages, cigarettes and tobacco products, for at-list 48 hours, prior to study check-in. * negative results for drugs of abuse in urine and alcohol breath analysis during check-in of each period. * not consumed grape fruit juice within the 48 hours prior to study check-in. exclusion criteria: * blood pressure systolic\> 140 mm hg and \ 90 mm hg * history of seizures * history of alcohol consumption for more than 2 units/day. * high caffeine or tobacco consumption * history of difficulty with donating blood or difficulty in accessibility of veins. * any unusual or abnormal diet, for whatever reason e.g. fasting due to religious reasons. * used any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study.
pain and stress assessment in children

Conditions: Acute Respiratory Infections

Summary: there may be pain and / or stress with vibrocompression. there may be pain and / or stress with the aspiration of secretions.

randomization to 10 children and 10 vibrocompression for aspiration of secretion. fill in the evaluation form. monitoring heart rate and peripheral o2 saturation (rest, during and after the technique performed). photographic record (rest, during and after the technique performed). saliva collection (rest, 5, 20 and 40 minutes after running technics). data analysis.

Eligibility criteria:
inclusion criteria: * indication of respiratory therapy fasting for one hour before the moment of collection term of free and informed consent form (icf) signed by parents or legal guardians exclusion criteria: * children in postoperative period acute presence of thoracic drain or mediastinal children using drugs to sedative or analgesic purpose of deep sedation

Keywords: pain stress physiotherapy children
investigation of the effect of different eye exercises on hypermetropia in school-age children

Conditions: Hyperopia

Summary: hypermetropia in school-aged children is a pathology which is very common and responds to treatments early. no studies have been found in the literature on the efficancy of the hypermetropia treatments with physiotherapy methods. in our study, it was aimed to investigate the effects of different eye exercises on hypermetropia defects in school age children aged 7-17 years and to determine whether exercise protocols have superiority against each other.

60 volunteer school-aged children (30 girls, 30 boys, between 7-17 years of age) were included in our study. 60 participants were randomly divided into three groups: eye exercises, convergence exercises and oculomotor exercise groups. home exercise protocols were given to all groups for 2 sessions per day for 6 weeks, and regular phone calls were made once a week. participants were assessed for their hypermetropic grades by autorefractometry, visual acuity by snellen chart, near and sharp visual acuity by activities of daily vision scale, and the health-related quality of life by pediatric quality of life inventory 4.0 version (pedsqi 4.0) children report.

Eligibility criteria:
inclusion criteria: * having hypermetropia eye defects * max. having a 1.50 d astigmatism defect * using glasses * having mental capacity in the level to understand and do exercises * not having systemic disease preventing exercise exclusion criteria: * having undergone eye surgery * having more than 1.50 d astigmatism defect * not using glasses

Keywords: eye exercises convergence exercise hyperopia oculomotor exercise school-age children
ketosis impact on signs & symptoms of schizophrenia and bipolar disorders

Conditions: Schizophrenia and Related Disorders; Psychosis; Bipolar and Related Disorders; Manic Episode; Depressive Episode

Summary: the goal of this clinical trial is to learn if a ketone drink can improve signs and symptoms of patients with a schizophrenia-spectrum disorder (ssd), or a bipolar-spectrum disorder (bd). the main questions it aims to answer are: does a ketone drink improve information processing in patients with ssd/bd? other questions it aims to answer are: does a ketone drink improve cognitive functioning in patients with ssd/bd? does a ketone drink improve metabolism and inflammation in patients with ssd/bd? does a ketone drink affect circadian rhythm in patients with ssd/bd? research will compare the effects of the ketone drink with that of an isocaloric carbohydrate drink in the same patients ('cross-over'). participants will: 1. drink a ketone drink and (after a wash-out period) an isocaloric control drink (randomized order); after each drink: * eeg/emg to determine information-processing parameters (ppi and p300) * cognitive tests * visual analog scale of mood, energy levels, ability to focus * indirect calorimetry to determine use of energy substrate * blood draws 2. for 5 consecutive days: * wear a continuous glucose monitor (cgm) * wear a non-invasive passive sweat biomarker sensor (enlisense device) * register a diet and nicotine diary * saliva sampling (max. 5x/day)


Eligibility criteria:
inclusion criteria: * patients with a first-episode psychosis (underlying schizophrenia-spectrum disorder), or patients with a (hypo)manic or depressive episode (underlying bipolar disorder) * age \>= 18 years old * receiving standard care (including antipsychotic and mood stabilizing medication) * mentally competent to give informed consent: exclusion criteria: * substance use as cause of psychosis or (hypo)mania * substance use (other than nicotine) in the week prior to study onset * intellectual disability * diabetes mellitus (type 1 or type 2) * metabolic disease impacting ketone metabolism (nb: these are rare disorders diagnosed during childhood) * liver disease * kidney disease * cardiovascular disease * pregnancy * breastfeeding